All referenced publications and patent applications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed inventions, or that any publication specifically or implicitly referenced is prior art.
Gluten is a plant protein occurring in wheat, rye, barley, oats, and other related grains and is commonly found in all foods that contain these grains. Gluten is used as an adhesive and as a flour substitute. A large portion of the human population cannot tolerate gluten when it comes in contact with the small intestine. This condition is known as Celiac Disease (sometimes called non-tropical sprue or gluten sensitive enteropathy). Celiac Disease is a common genetic disease in Europe and is also extremely widespread in the United States. About 1 in 250 people in Italy, 1 in 300 people in Ireland and 1 in 133 Americans are afflicted with this disease (Fasano 2003; U.S. Pat. No. 6,709,686).
When people with Celiac Disease eat foods containing gluten, their immune system responds by damaging the small intestine. Specifically, tiny fingerlike protrusions, called villi, on the lining of the small intestine are lost. Normally, nutrients from food are absorbed into the bloodstream through these villi. Without villi, a person becomes malnourished—regardless of the quantity of the food eaten. Symptoms of Celiac Disease may include one or more of the following: recurring abdominal bloating and pain, chronic diarrhea, weight loss, pale foul-smelling stool, unexplained anemia, gas, bone pain, behavior changes, muscle cramps, fatigue, delayed growth, failure to thrive in infants, pain in the joints, seizures, tingling numbness in the legs resulting from nerve damage, pale sores inside the mouth known as aphthus ulcers, painful skin rash known as dermatitis, herpetiformis, tooth discoloration or loss of enamel, and missed menstrual periods (U.S. Pat. No. 6,709,686).
Current treatment is effected by a well-balanced gluten-gliadin-free diet high in calories and proteins and normal in fat. U.S. Pat. No. 4,958,418; WO 99/56698 and Japanese Patent No. 1156927 each teach other treatments for patients affected by Celiac Disease that are not responding to gluten-gliadin-free diets. Unfortunately the only truly effective treatment is to follow a gluten-free diet. This means eliminating virtually all foods made from these grains (e. g., food starch when it is prepared from wheat, and malt when it comes from barley). The gluten-free diet is a lifetime requirement. Individuals following such a diet have an incredibly difficult time eating at restaurants due to the presence of gluten in much of the food on the menus. As such, a need exists for new gluten-free products.
The seed of Timothy grass (Phleum pratense L) contains essentially no gluten. We have discovered that flour obtained from Timothy seed can be milled and baked in manner similar to wheat and can be used to manufacture gluten-free food products. The products of this invention can be used as nutraceuticals for the control of Celiac Disease in human beings.